Clopidogrel ratiopharm

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

The marketing authorisation for Clopidogrel ratiopharm has been withdrawn at the request of the marketing-authorisation holder.

Clopidogrel ratiopharm : EPAR - Summary for the public

Product information

Clopidogrel ratiopharm : EPAR - Product Information

Latest procedure affecting product information: N/0016

25/10/2013

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Clopidogrel ratiopharm : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel ratiopharm
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
• Anatomical therapeutic chemical (ATC) code:
  B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

• patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

For further information please refer to section 5.1.

Authorisation details

• EMA product number:
  EMEA/H/C/001173
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Archie Samuel s.r.o.

  Slunná 16 ; 61700 Brno ; Czech Republic

• Marketing authorisation issued:
  23/09/2009
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Clopidogrel ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel ratiopharm-H-C-1173-A20-08 : EPAR - Assessment Report - Article 20

Adopted

Initial marketing authorisation documents

Clopidogrel ratiopharm : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Clopidogrel ratiopharm

Reference Number: EMEA/CHMP/375222/2009